Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)GLORIANCT07609355
AI-Assisted Optimization of Online Adaptive Radiotherapy for Gastric Lymphoma
A study testing ART in people with Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT), run by Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate CBCT image-based triggered online adaptive radiotherapy (ART) and assess its clinical benefits in protecting organs at risk (OARs). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)
- What is being tested?
- ART
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG Performance Status: 0 or 1, with no deterioration within the 2 weeks prior to enrollment.
- Age: ≥18 years and ≤75 years.
- Diagnosis \& Stage: Pathologically confirmed primary gastric lymphoma, staged as I, II, or IIE according to the Lugano modified staging system.
- Treatment Plan: Deemed by both medical oncology and radiation oncology physicians to be candidates for definitive radiotherapy or consolidative radiotherapy following chemotherapy, based on assessment prior to enrollment.
- Adequate Organ Function (including Bone Marrow Function, Hepatic Function, Coagulation Function, Renal Function, Cardiac Function)
- Informed Consent \& Compliance: Voluntarily participate, provide written informed consent, and be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- Known history of malignancy (excluding patients with basal cell carcinoma of the skin, superficial bladder cancer, cutaneous squamous cell carcinoma, carcinoma in situ, or papillary thyroid carcinoma who have undergone curative surgery).
- Prior abdominal or pelvic radiotherapy within the past 3 years. Women who are pregnant or breastfeeding (women of childbearing potential must consider pregnancy testing; effective contraception must be emphasized during treatment).
- Inability to undergo contrast-enhanced magnetic resonance imaging (MRI) due to factors such as allergy to MRI contrast agents or claustrophobia.
- Any other disease or clinically significant laboratory abnormality, severe medical or psychiatric condition/disorder, or substance abuse (including alcohol abuse) considered by the investigator as potentially compromising patient safety, the integrity of the study, patient participation, or interfering with the study objectives and analysis of results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Chun-Yan Chen, Prof., 020-87342926, chenchuny@sysucc.org.cn
About this study
Official title: AI-Assisted Optimization of Online Adaptive Radiotherapy for Gastric Lymphoma: A Prospective Single-Arm Phase II Exploratory Study
The goal of this clinical trial is to evaluate CBCT image-based triggered online adaptive radiotherapy (ART) and assess its clinical benefits in protecting organs at risk (OARs).
- Being tested
- ART
- Keywords
- AI, Online Adaptive Radiotherapy, Gastric Lymphoma, Exploratory
- Medical subject headings
- Familial primary gastric lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTRadiation
All participants will receive intensity-modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT). To ensure study quality, all radiation therapy plans will undergo review by the research team at Sun Yat-sen University Cancer Center. Target volume delineation will adhere to the involved-site radiation therapy (ISRT) principles recommended by the International Lymphoma Radiation Oncology Group (ILROG) consensus guidelines. Treatment will be categorized based on intent: definitive radiation therapy or consolidative radiation therapy. The ART process primarily includes: imaging acquisition → AI-assisted automatic contouring → adaptive decision-making → plan optimization → verification → treatment delivery and documentation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | This study is a prospective, single-arm, phase II exploratory trial. The primary objectives are to preliminarily evaluate the feasibility and safety of AI-assisted adaptive radiation therapy (ART) for the treatment of gastric lymphoma patients and to explore its preliminary efficacy. Receives: Radiation: ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients successfully completing the full course of ART treatment
Defined as the proportion of patients who complete ≥90% of the planned fractions of the online ART process. This includes successful completion of online image evaluation, plan modification (if required), verification that the modified plan meets preset criteria (OARs dose constraints, PTV coverage ≥95%), dose verification, and successful treatment delivery. Cases where treatment is not completed due to technical failures causing delays >60 minutes, or patient intolerance (e.g., vomiting/pain requiring interruption, or positional shifts >5mm that cannot be corrected) are excluded from this success metric.
Measured: End of ART
Objective Response Rate (ORR)
Defined as the sum of patients achieving Complete Response (CR) and Partial Response (PR) according to the 2014 Lugano Classification for response assessment, divided by the number of patients in the analysis set. That is, ORR = (CR + PR) / Number of patients in the analysis set. Response assessment is performed 3 months after the last fraction of radiotherapy, categorized as either radiographic response (assessed by CT/MRI) and/or metabolic response (assessed by PET/CT).
Measured: Imaging assessment at approximately 12 weeks (3months) after completion of radiotherapy
Secondary outcomes (8)
1-year Progression-Free Survival (PFS) Rate
PFS is defined as the time from the day of first study drug administration to tumor progression (in any aspect) or death (from any cause).
Measured: At 12 months post-radiotherapy
1-year Overall Survival (OS) Rate
OS is defined as the time from Day 1 of treatment to death from any cause.
Measured: At 12 months post-radiotherapy
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Throughout this study and during the follow-up period, the proportion of patients experiencing ≥Grade 2 radiotherapy-related toxicities (per CTCAE v5.0). Acute phase: From Day 1 of radiotherapy to 3 months post-treatment.
Late phase: From 3 months to 1 year post-radiotherapy. Late toxicities include but are not limited to gastrointestinal events (e.g., gastric ulcer, hemorrhage, stenosis), hepatic toxicity, or other organ toxicities.
Measured: From the first day of radiation therapy initiation to within 3 months, 6 months, and 12 months after completion.
Quality of Life (QoL)
The QoL was assessed at baseline and during follow-up using the EORTC Quality of Life Questionnaire Core 30 (QLQ-C30), Version 3.0, which represent functions, symptoms, or health conditions. The EORTC QLQ-C30: a quality of life instrument for use in international clinical trials in oncology. A total of 30 items are included. Each item is graded from 1 to 4, except for items 29 and 30, indicating not at all, a little, quite a bit, and very much, with higher scores indicating poorer quality of life.
Measured: Baseling, 1 month, 3 months, 6 months, 12 months post-radiotherapy
EORTC Quality of Life Questionnaire-Gastric Cancer Module
The QoL STO22 was assessed at baseline and during follow-up using the EORTC Quality of Life Questionnaire-Gastric Cancer Module (QLQ-STO22). The EORTC QLQ-STO22: a quality of life instrument for use in international clinical trials in gastric cancer. A total of 22 items are included. Each item is graded from 1 to 4, indicating not at all, a little, quite a bit, and very much, with higher scores indicating poorer quality of life.
Measured: Baseling, 1 month, 3 months, 6 months, 12 months post-radiotherapy
Patient-Reported Quality of Life (PRO-QoL) Deterioration Rate
Defined as the assessment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTCQLQ-C30), from baseline to 1 month post-radiotherapy completion.
Measured: Baseline and 1 month post-radiotherapy
Average duration per online ART session (from CBCT start to beam-on)
Measured: Periprocedural of ART
Evaluation of actual target coverage throughout the entire treatment (assessed as the fraction of treatment sessions where PTV D95% ≥ 95% of the prescribed dose)
Measured: From the first treatment session through the end of ART, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start8 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Chunyan, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07609355
- Sponsor's protocol ID
- 2026-FXY-065
- Acronym
- GLORIA
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Assisted Optimization of Online Adaptive Radiotherapy for Gastric Lymphoma: A Prospective Single-Arm Phase II Exploratory Study
- ClinicalTrials.gov ID
- NCT07609355
- Acronym / sponsor ID
- GLORIA / 2026-FXY-065
- Keywords
- AI, Online Adaptive Radiotherapy, Gastric Lymphoma, Exploratory
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 8 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate CBCT image-based triggered online adaptive radiotherapy (ART) and assess its clinical benefits in protecting organs at risk (OARs).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Radiation: ARTThis study is a prospective, single-arm, phase II exploratory trial. The primary objectives are to preliminarily evaluate the feasibility and safety of AI-assisted adaptive radiation therapy (ART) for the treatment of gastric lymphoma patients and to explore its preliminary efficacy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ECOG Performance Status: 0 or 1, with no deterioration within the 2 weeks prior to enrollment.
- Age: ≥18 years and ≤75 years.
- Diagnosis \& Stage: Pathologically confirmed primary gastric lymphoma, staged as I, II, or IIE according to the Lugano modified staging system.
- Treatment Plan: Deemed by both medical oncology and radiation oncology physicians to be candidates for definitive radiotherapy or consolidative radiotherapy following chemotherapy, based on assessment prior to enrollment.
- Adequate Organ Function (including Bone Marrow Function, Hepatic Function, Coagulation Function, Renal Function, Cardiac Function)
Key exclusion criteria (4 listed)
- Known history of malignancy (excluding patients with basal cell carcinoma of the skin, superficial bladder cancer, cutaneous squamous cell carcinoma, carcinoma in situ, or papillary thyroid carcinoma who have undergone curative surgery).
- Prior abdominal or pelvic radiotherapy within the past 3 years. Women who are pregnant or breastfeeding (women of childbearing potential must consider pregnancy testing; effective contraception must be emphasized during treatment).
- Inability to undergo contrast-enhanced magnetic resonance imaging (MRI) due to factors such as allergy to MRI contrast agents or claustrophobia.
- Any other disease or clinically significant laboratory abnormality, severe medical or psychiatric condition/disorder, or substance abuse (including alcohol abuse) considered by the investigator as potentially compromising patient safety, the integrity of the study, patient participation, or interfering with the study objectives and analysis of results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARTAll participants will receive intensity-modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT). To ensure study quality, all radiation therapy plans will undergo review by the research team at Sun Yat-sen University Cancer Center. Target volume delineation will adhere to the involved-site radiation therapy (ISRT) principles recommended by the International Lymphoma Radiation Oncology Group (ILROG) consensus guidelines. Treatment will be categorized based on intent: definitive radiation therapy or consolidative radiation therapy. The ART process primarily includes: imaging acquisition → AI-assisted automatic contouring → adaptive decision-making → plan optimization → verification → treatment delivery and documentation. | Radiation | Intervention arm |
Primary outcome
Proportion of patients successfully completing the full course of ART treatment
Time frame: End of ART
Defined as the proportion of patients who complete ≥90% of the planned fractions of the online ART process. This includes successful completion of online image evaluation, plan modification (if required), verification that the modified plan meets preset criteria (OARs dose constraints, PTV coverage ≥95%), dose verification, and successful treatment delivery. Cases where treatment is not completed due to technical failures causing delays >60 minutes, or patient intolerance (e.g., vomiting/pain requiring interruption, or positional shifts >5mm that cannot be corrected) are excluded from this success metric.
Objective Response Rate (ORR)
Time frame: Imaging assessment at approximately 12 weeks (3months) after completion of radiotherapy
Defined as the sum of patients achieving Complete Response (CR) and Partial Response (PR) according to the 2014 Lugano Classification for response assessment, divided by the number of patients in the analysis set. That is, ORR = (CR + PR) / Number of patients in the analysis set. Response assessment is performed 3 months after the last fraction of radiotherapy, categorized as either radiographic response (assessed by CT/MRI) and/or metabolic response (assessed by PET/CT).
8 secondary outcomes
1-year Progression-Free Survival (PFS) Rate
Time frame: At 12 months post-radiotherapy
1-year Overall Survival (OS) Rate
Time frame: At 12 months post-radiotherapy
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: From the first day of radiation therapy initiation to within 3 months, 6 months, and 12 months after completion.
Quality of Life (QoL)
Time frame: Baseling, 1 month, 3 months, 6 months, 12 months post-radiotherapy
EORTC Quality of Life Questionnaire-Gastric Cancer Module
Time frame: Baseling, 1 month, 3 months, 6 months, 12 months post-radiotherapy
Patient-Reported Quality of Life (PRO-QoL) Deterioration Rate
Time frame: Baseline and 1 month post-radiotherapy
Average duration per online ART session (from CBCT start to beam-on)
Time frame: Periprocedural of ART
Evaluation of actual target coverage throughout the entire treatment (assessed as the fraction of treatment sessions where PTV D95% ≥ 95% of the prescribed dose)
Time frame: From the first treatment session through the end of ART, an average of 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ART in people with Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT), run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chun-Yan Chen, Prof. (020-87342926, chenchuny@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients successfully completing the full course of ART treatment (time frame: End of ART). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.